- Second of five planned cohorts ongoing in Phase 1/2a trial of GLIX1 in GBM; third patient cohort expected to commence dosing in September -
- Announced new data showing GLIX1 achieved potent antitumor activity in TMZ-resistant patient-derived xenograft (PDX) GBM in vivo model -
- Announced additional data demonstrating strong synergistic effect between GLIX1 and PARP inhibitor in patient-derived HR-proficient ovarian cancer xenograft model -
- Management to host conference call today, August 31, at 8:30 am EDT -
TEL AVIV, Israel, Aug. 31, 2026 /PRNewswire/ -- BioLineRx Ltd. $(BLRX)$ (TASE: BLRX), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the quarter ended June 30, 2026, and provided a corporate update.
"During the second quarter and subsequent period, we advanced GLIX1 across multiple fronts," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Our Phase 1/2a study in glioblastoma is advancing as planned, with the second cohort in the Phase 1 part now being dosed, and the third cohort expected to commence dosing in September. To date, a little more than four months into the study, we have been very pleased with the drug's safety and tolerability.
"Also, during the quarter, we were excited to demonstrate the potential of GLIX1 to address unmet needs for GBM as well as ovarian cancer in a number of pre-clinical models. In this regard, we announced new data in a temozolomide-resistant patient-derived xenograft (PDX) GBM in-vivo model, in which GLIX1 demonstrated a robust anti-tumor effect while TMZ showed no effect. These results further support GLIX1's potential to treat a broad range of patients with GBM. We also generated data showing strong synergy between GLIX1 and PARP inhibitors in an HR-proficient patient-derived ovarian cancer in-vivo model, and based upon these excellent findings, we are planning to add an ovarian cancer arm to the Phase 2a expansion phase of the trial. Together, these developments keep GLIX1 on track in glioblastoma while extending its reach into additional tumor types where new treatment options are desperately needed."
Financial Updates
-- With $13.1 million on its balance sheet as of June 30, 2026, BioLineRx is
maintaining its cash runway guidance into the first half of 2027.
-- On August 27, 2026, the Company entered into a definitive agreement for
an offering with gross proceeds of $3.75 million, expected to close on or
about August 31, 2026.
Development Updates
GLIX1 in GBM
-- In July, dosing commenced in the second of five planned cohorts in the
Phase 1 dose escalation part of the Phase 1/2a study.
-- Three leading cancer centers are enrolling patients in the Phase 1
part of the study: NYU Langone Health, led by Dr. Alexandra
Miller; Northwestern University, led by Dr. Roger Stupp and Dr.
Ditte Primdahl; and Moffit Cancer Center, led by Dr. Patrick
Grogan.
-- The Phase 1 part of the trial is expected to recruit up to 30
patients with recurrent and progressive GBM and other high-grade
gliomas. The objective is to establish a maximum tolerated dose
$(MTD)$ and/or a recommended dose based on safety, PK/PD and
preliminary efficacy.
-- The Phase 2a expansion part of the trial is planned to include
various population cohorts, including GBM (newly diagnosed and/or
recurrent), as well as additional cancers with/without standard of
care (e.g., PARP inhibitors), including an ovarian cancer arm.
These cohorts are expected to identify preliminary efficacy, PD
assessments and dose optimization data, serving as the basis for
rapid and effective advanced clinical development.
-- New data demonstrated potent anti-tumor effect of GLIX1 in GBM across
multiple in-vivo studies, including a temozolomide (TMZ)-resistant
patient-derived xenograft model. In the three orthotopic CDX studies,
significant tumor growth inhibition and survival benefit were observed
following treatment with GLIX1 across all doses tested, with greater
benefit at higher dose levels. Most notably, in the subcutaneous PDX
model, GLIX1 demonstrated a robust anti-tumor effect while TMZ showed no
effect.
-- Clinical and pre-clinical data have been accepted for publication at
the European Association of Neuro-Oncology (EANO) 2026 Conference and at
the Society for Neuro-Oncology (SNO) 2026 Annual Meeting.
GLIX1 in combination with PARPi
-- New data demonstrated strong synergy between GLIX1 and PARP inhibitors,
reinforcing synthetic lethality between GLIX1 and PARP inhibitors.
-- Synergy was demonstrated in a patient-derived xenograft (PDX)
in-vivo model of HR-proficient ovarian cancer, where PARP
inhibitors have historically had limited efficacy. Results show
substantially better efficacy in the combination arm versus the
control arm and versus the monotherapy arms, despite using lower
doses in the combination arm. Notably, the low-dose GLIX1/olaparib
combination tumor reduction was similar to cisplatin, the current
chemotherapy benchmark.
-- An abstract featuring new GLIX1 data, demonstrating synergy with PARP
inhibitors in HR-proficient ovarian cancer, was accepted for publication
at the 2026 European Society for Medical Oncology Annual Congress (ESMO
2026) in October.
-- BioLineRx has initiated discussions with leading PARP inhibitor companies
to explore potential development collaborations.
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)
-- Enrollment is continuing in the CheMo4METPANC Phase 2b clinical trial,
which is being led by Columbia University, and supported by both
Regeneron and BioLineRx. The trial is evaluating motixafortide in
combination with the PD-1 inhibitor cemiplimab and standard chemotherapy
(gemcitabine and nab-paclitaxel).
-- A prespecified interim/futility analysis is planned when 40% of
progression-free survival (PFS) events are observed, which the
Company continues to anticipate will occur in 2026.
APHEXDA Performance Update
-- For the second quarter of 2026, APHEXDA sales were $1.6 million, which
provided royalty revenue to the Company of $0.3 million.
Financial Results for the Quarter ended June 30, 2026
-- Revenues for the three months ended June 30, 2026 were $0.3 million,
similar to the three months ended June 30, 2025.
-- Research and development expenses for the three months ended June 30,
2026 were $2.9 million, an increase of $0.6 million, or 26.5%, compared
to $2.3 million for the comparable 2025 period. The increase resulted
primarily from expenses related to the new GLIX1 project, offset by lower
expenses related to motixafortide.
-- General and administrative expenses for the three months ended June 30,
2026 were $0.9 million, an increase of $0.7 million, or 313.9%, compared
to $0.2 million for the comparable 2025 period. The increase resulted
from the reversal of a $0.8 million provision for doubtful accounts in
the 2025 period following receipt of an overdue milestone payment from
Gloria.
-- Non-operating expenses amounted to $0.7 million for the three months
ended June 30, 2026, compared to non-operating expenses of $1.9 million
for the three months ended June 30, 2025. Non-operating expenses for both
periods primarily relates to fair-value adjustments of warrant
liabilities on the Company's balance sheet.
-- Net financial expenses for the three months ended June 30, 2026 were $0.1
million compared to net financial income of $0.2 million for the three
months ended June 30, 2025. Net financial expenses in 2026 primarily
relate to interest paid on loans, partially offset by investment income
earned on bank deposits. Net financial income in 2025 primarily relates
to investment income earned on bank deposits and gains on foreign
currency cash balances due to the strengthening of the NIS during the
period, partially offset by interest paid on loans.
-- Net loss for the three months ended June 30, 2026 was $4.3 million,
compared to $3.9 million for the three months ended June 30, 2025.
-- As of June 30, 2026, the Company had cash, cash equivalents, and
short-term bank deposits of $13.1 million.
Conference Call and Webcast Information
To access the conference call, please dial +1-888-407-2553 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until September 1, 2026; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company's lead development asset is GLIX1, a first-in-class, oral, small molecule targeting DNA damage response in glioblastoma and other solid tumors, for which a Phase 1/2a clinical trial was initiated in the first quarter of 2026. GLIX1 is being developed under a collaboration with Hemispherian AS.